PDA News

Parenteral Packaging Concerns for Biologics

by
Graham Reynolds and Mike Schaefers, PhD, West | Mar 26, 2014

Bringing a new biological drug to market requires a huge financial commitment and entails risks in every stage of the development process. The risks associated with selecting the appropriate component for packaging the drug may not be at the forefront of early stage thinking, but are real nonetheless and can have a profound impact on the drug product. Packaging components must meet functional requirements to ensure safety at the point of administration and protect the purity of the packaged drug product for its shelf-life, usually a minimum of two years.

Bringing a new biological drug to market requires a huge financial commitment and entails risks in every stage of the development process. The risks associated with selecting the appropriate component for packaging the drug may not be at the forefront of early stage thinking, but are real nonetheless and can have a profound impact on the drug product. Packaging components must meet functional requirements to ensure safety at the point of administration and protect the purity of the packaged drug product for its shelf-life, usually a minimum of two years.

Growth in biologics has driven the need for novel primary containment materials and unique delivery systems, and the increase in biosimilars has served to heighten the requirement for packaging and delivery innovation. A drug is effective, however, only if it can be delivered to the patient in a way that helps ensure compliance with the prescribed regimen. By focusing on the science, engineering and regulation of primary packaging for injectable biotech drugs early in the drug development process, pharmaceutical companies can not only bring an effective and safe drug product to market, but also differentiate that product with unique packaging and delivery that may help aid patient compliance.

Start with the End in Mind

The process for selecting primary containment materials compatible with a pharmaceutical product and its intended use is an important aspect of safe and effective delivery. In today’s regulatory environment, assessing and managing risk early in the development process is critical to successful development and commercialization of drug products. The physical and chemical nature of the materials used for primary containment, however, can exhibit behavior that has the potential to compromise the drug product, which may result in harm to the patient. Many biologic drug products have known sensitivities, including negative reactions to metal ions such as zinc. There may be additional issues that cannot be predicted based on the protein or the molecule.

Even though glass has a long history of use with a variety of pharmaceutical products, many drug products have been recalled in the past few years due to glass-related issues such as delamination or breakage. It can be difficult to determine the ultimate cause of delamination, but early testing and informed selection of materials may help mitigate risk. Additional considerations such a permeation, leaching, sorption, chemical interactions, dimensional consistency, alteration of the physical properties and ensuring functional characteristics of both drug and packaging during processing, storage and distribution is critical to success.

Component Selection: Quality Questions

Several considerations can be made during the development process that will help ensure a quick route to market. First, biopharmaceutical manufacturers should consider the needs of the drug product itself. Is the product sensitive to glass? Many products may have characteristics that would require a polymer containment system. Additionally, dose size may affect the packaging decision. Larger or more viscous doses should be administered over a longer period of time to aid in patient comfort and adherence. For a large volume dose, typical delivery systems may not be capable of providing a single dose option. Instead, a multidose primary container that can be used within a pen or other delivery system may be required. Finally, how will the product be stored and shipped? Will glass delamination or breakage—particularly for drugs stored at low temperatures—be a risk?

Understanding these criteria at the beginning of the development cycle requires an integrated approach that takes not only the needs of the drug product, but also the needs of the patient or caregiver and the final delivery system, into account. High-quality components manufactured based on the identification and control of critical process parameters, rather than a rigid, static operation that is more susceptible to multiple manufacturing changes, will create a more consistent product.

Filling issues should also be considered. Guidance and experience from a filling perspective can be invaluable when it comes to proper handling of components, particularly if the delivery method includes a prefillable syringe, where vacuum placement can be an issue. Modern plunger placement techniques can help avoid issues such as wrinkling and deformation of the plungers.

The right packaging may help engender patient loyalty, particularly in the biosimilar markets where method of delivery may impact a patient’s choice of product. By asking the right questions and making the best selections early in the development process, packaging and pharmaceutical manufacturing can mitigate risk and deliver a high-quality product to patients.

About the Authors

Graham Reynolds leads initiatives to market novel delivery systems and develop strategies for future growth, including the acquisition and development of new technologies.

As Vice President Global Marketing, Mike Schaefers is responsible for the global Marketing activities of West’s Pharmaceutical Packaging Systems Division.

[Editor’s Note: West Pharmaceuticals will be exhibiting at Tabletop #11 at the 2014 PDA Packaging Conference.]